Newsroom
79 articles
Important Eurneffy (epinephrine) is an alternative to injectable formulations, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization in the European Union for Eurneffy (epinephrine), the first…
Important EMA’s human medicines committee (CHMP) has concluded its review of the medicine Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorisation be revoked, because its benefits…
Important Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially with prolonged use…
Important The Product Information (PI) documents for all selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) have been aligned to reflect the risk of sexual…
Important New boxed warnings are being added to the patient information leaflets (PIL) of montelukast due to neuropsychiatric reactions as a result of MHRA review More prominent warnings are…
Important The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 May 2024) approved two new formulations of the medicine cabotegravir (Apretude 30 mg film-coated tablets and Apretude…
Important ETF recommends updating COVID-19 vaccines to target new JN.1 variant Updated vaccines will help maintain protection against disease as virus continues to evolve, MA’s Emergency Task Force (ETF)…
Important PRAC committee latest meeting doesn’t support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) and suicidal and self-injurious thoughts and actions The PRAC has concluded that…
Important TGA Updated warnings of faricimab (Vabysmo) retinal vasculitis risk Faricimab is indicated for: Neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) Faricimab 6 mg/0.05 mL…
Important FDA Warns Consumers about Potential for Dangerous Health Effects that can result from Certain Topical Pain Relief Products The U.S. Food and Drug Administration is warning consumers not…
Important Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to…
Important Pseudoephedrine is licensed for the symptomatic relief of nasal and sinus congestion in colds, flu, and allergies. It has been used in the UK for decades by millions…
Important Dear Healthcare Providers, We are writing to inform you of an important safety notice regarding Terumo Platelet Additive Solution+ (T-PAS+). Please carefully review the following information: Device Details:…
Featured We want to bring to your attention an urgent recall affecting two specific batches of Lipocomb capsules, Lipocomb 10 mg/10 mg (batch PPA0465/460/001) and Lipocomb 20 mg/10 mg…
Important We would like to bring to your attention an important recall notice regarding Ketofall 0.25 mg/ml Eye Drops Solution in single-dose containers. Background Information: The Health Products Regulatory…
Talk to our experts and get tailored solutions to help you stay compliant and move forward with confidence.
Submit RFI/RFP
Request Consultation
Submit RFI/RFP